: This is an application to renew a clinical trials unit (CTU) in Botswana, which has the second-highest prevalence of HIV in the world but also a sympathetic and interested government. This program will engage in research related to adult HIV therapeutic strategies (including antiretroviral treatment strategies, the diagnosis/management of noninfectious co-morbidities, and the infectious co-morbidities of hepatitis and tuberculosis);strategies to address HIV and HIV-associated infections/conditions in piediatric and maternal populations;integrated HIV prevention strategies in pediatric and adult populations;and vaccines to prevent HIV infection. These activities will occur through participation in four networks: ACTG, IMPAACT, HPTN, and HVTN. The objectives are to help develop and facilitate strategies for prevention and treatment of HIV infection and HIV-related illnesses (and for HIV vaccines) that are relevant for alleviating the epidemic in sub-Saharan Africa and elsewhere. Investigators and other key personnel from the Botswana CTU will participate in and contribute to network scientific and leadership activities in all areas, including joining and potentially leading protocol teams and scientific / resource committees ofthe networks with which this CTU will be affiliated. The Botswana CTU will conduct an integrated program for clinical research that includes clinical and laboratory activities. Two established clinical research sites (in Gaborone and Molepolole) will be affiliated with this CTU, and will allow efficient enrollment of participants in both urban and village populations into trials in Botswana. The investigators and staff are highly experienced in AIDS research, including trials in all proposed research areas, and have a strong record of collaboration with national and international agencies and networks, and a substantial record of having completed trials with very high standards. The combined resources of the Botswana CTU are substantial for both facilities and personnel.

Public Health Relevance

The Botswana CTU will develop and study strategies for preventing and treating HIV infection and HIV-related illnesses that are relevant to the severe HIV epidemic in sub-Saharan Africa and elsewhere. This will include studies related to treating HIV in HIV-infected adults and children;preventing sexual and perinatal transmission of HIV;improving the health of HIV-infected mothers and their children;and studying vaccines designed to prevent the transmission of HIV.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-VV-A (S1))
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Tauscher, Gail H
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Harvard University
Schools of Public Health
United States
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Beneri, C A; Aaron, L; Kim, S et al. (2016) Understanding NIH clinical case definitions for pediatric intrathoracic TB by applying them to a clinical trial. Int J Tuberc Lung Dis 20:93-100
Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 72:304-9
Tuluc, Florin; Spitsin, Sergei; Tustin, Nancy B et al. (2016) Decreased PD-1 Expression on CD8 Lymphocyte Subsets and Increase in CD8 Tscm Cells in Children with HIV Receiving Raltegravir. AIDS Res Hum Retroviruses :
Borges, Álvaro H; Lundh, Andreas; Tendal, Britta et al. (2016) Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection: A Systematic Review and Metaanalysis of Randomized Trials. Clin Infect Dis 63:268-80
TenoRes Study Group (2016) Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study. Lancet Infect Dis 16:565-75
Cohen, Myron S; Chen, Ying Q; McCauley, Marybeth et al. (2016) Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med 375:830-9
Luetkemeyer, Anne F; Rosenkranz, Susan L; Lu, Darlene et al. (2015) Combined effect of CYP2B6 and NAT2 genotype on plasma efavirenz exposure during rifampin-based antituberculosis therapy in the STRIDE study. Clin Infect Dis 60:1860-3
Rizk, Matthew L; Du, Lihong; Bennetto-Hood, Chantelle et al. (2015) Population pharmacokinetic analysis of raltegravir pediatric formulations in HIV-infected children 4 weeks to 18 years of age. J Clin Pharmacol 55:748-56
Podany, Anthony T; Bao, Yajing; Swindells, Susan et al. (2015) Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention. Clin Infect Dis 61:1322-7
Nachman, Sharon; Alvero, Carmelita; Acosta, Edward P et al. (2015) Pharmacokinetics and 48-Week Safety and Efficacy of Raltegravir for Oral Suspension in Human Immunodeficiency Virus Type-1-Infected Children 4 Weeks to 2 Years of Age. J Pediatric Infect Dis Soc 4:e76-83

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